Stimulation device and method

ABSTRACT

A stimulation device for creating a pleasurable sensation in a user is provided. The stimulation device includes an expandable portion configured to assume a plurality of states of expansion between minimum expansion and maximum expansion and a vibrating element extending away from the outer surface of the expandable portion.

CROSS-REFERENCE TO RELATED PATENT APPLICATIONS

This application is related to and claims priority to PCT ApplicationNo. PCT/US2011/040714, filed on Jun. 16, 2011, which is related to andclaims priority to U.S. Provisional Application No. 61/430,072, filedJan. 5, 2011, and to U.S. Provisional Application No. 61/355,822, filedJun. 17, 2010, all of which are incorporated herein by reference intheir entireties.

BACKGROUND

The present disclosure relates generally to the field of nerve andmuscle stimulation. One aspect of the present disclosure relates to adevice and method for electronic nerve and muscle stimulation, and inparticular, internal tissue stimulation. The present disclosure relatesspecifically to a device and method for creating a pleasurable sensationin a user using electronic nerve and muscle stimulation and/orvibrational nerve and muscle stimulation.

Some studies have indicated that more tightened and toned pelvic floormuscles increase the power and intensity of the female orgasm. Certainexercises may be performed to strengthen muscles in this area. Further,stimulation of particular nerves and muscles may be used to generate apleasurable or enjoyable feeling.

SUMMARY

One embodiment of the disclosure relates to a stimulation device forcreating a pleasurable sensation in a user including an expandableportion configured to assume a plurality of states of expansion betweenminimum expansion and maximum expansion and a vibrating elementextending away from the outer surface of the expandable portion.

Another embodiment of the disclosure relates to a stimulation device forcreating a pleasurable sensation in a user including a shaft having aproximal end and a distal end, the proximal end being interconnected toa housing, and an operative portion located between the proximal end andthe distal end and configured to be located within a vagina when thedevice is in an inserted position. Only one balloon circumferentiallysurrounds the operative portion of the shaft, and a first electrode anda second electrode are coupled to the outer surface of the balloon andconfigured to cause a contraction of a muscle in communication with theelectrodes. The balloon is configured to inflate such that the first andsecond electrodes press against at least one vaginal wall.

Another embodiment of the disclosure relates to a method of toningpelvic floor muscles including providing a device having an expandableportion having an outer surface, a first electrode, and a secondelectrode, causing the expandable portion to inflate such thatelectrodes contact at least one vaginal wall, and causing a contractionof a muscle in communication with the electrode. The first and secondelectrodes are coupled to the outer surface of the expandable portionand configured to cause a contraction of a muscle in communication withthe electrodes.

Another embodiment of the disclosure relates to a stimulation device forcreating a pleasurable sensation in a user including a shaft having aproximal end and a distal end, the proximal end being coupled to ahandle, an operative portion located between the proximal end and thedistal end and configured to be located within a vagina when the deviceis in an inserted position, and an expandable portion comprising anouter surface and configured to assume a plurality of states ofexpansion between minimum expansion and maximum expansion, theexpandable portion circumferentially surrounding the operative portionof the shaft. The device further includes a first electrode, a secondelectrode, a first vibrating element, and a second vibrating element,the first electrode coupled to a first portion of the outer surface ofthe expandable portion, the second electrode coupled to a second portionof the outer surface of the expandable portion, the first and secondelectrodes configured to cause a contraction of a muscle incommunication with the electrodes, the first vibrating element extendingaway from the outer surface of the expandable portion and configured toimpart vibration to a user's Gräfenberg Spot; and the second vibratingelement configured to impart vibration to a first portion of user'sbody. The device further includes a pump in communication with theexpandable portion and configured to cause inflation of the expandableportion such that at least one of the first electrode, the secondelectrode, and the first vibrating element press against a vaginal wall,and processing electronics configured to cause an electrical signal inthe electrodes, to control an aspect of vibration of the first vibratingelement, and to control an aspect of vibration of the second vibratingelement.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a perspective view of a stimulation device, shown according toan exemplary embodiment.

FIG. 2 is a perspective view of a portion of the device of FIG. 1, shownaccording to an exemplary embodiment.

FIG. 3 is a bottom plan view of the device of FIG. 1, shown according toan exemplary embodiment.

FIG. 4 is a top plan view of the device of FIG. 1, shown according to anexemplary embodiment.

FIG. 5 is an exploded perspective view of a portion of the device ofFIG. 1, shown according to an exemplary embodiment.

FIG. 6 is a longitudinal cross-section view of the device taken alongline 6-6 of FIG. 1, shown according to an exemplary embodiment.

FIG. 7A is a radial cross-section view of the device taken along line7-7 of FIG. 1 in a deflated state, shown according to an exemplaryembodiment.

FIG. 7B is a radial cross-section view of the device taken along line7-7 of FIG. 1 but showing the device in an inflated state, according toan exemplary embodiment.

FIG. 8 is a schematic block diagram of the device of FIG. 1, shownaccording to an exemplary embodiment.

FIG. 9 is a schematic block diagram of the processing electronics of thedevice of FIG. 1, shown according to an exemplary embodiment.

FIG. 10 is a schematic flow chart of a process for toning pelvic floormuscles, shown according to an exemplary embodiment.

FIG. 11 is a schematic flow chart of a process for toning pelvic floormuscles, shown according to another exemplary embodiment.

FIG. 12 is a schematic sagittal cross-sectional view of a user with thedevice of FIG. 1 in an inserted position, shown according to anexemplary embodiment.

DETAILED DESCRIPTION

Referring generally to FIGS. 1-12, a stimulation device for creating apleasurable sensation in a user and a method of toning pelvic floormuscles are shown according to exemplary embodiments. According to theembodiment shown, the device 101 includes a handle 111 and a probe 121,the probe 121 configured for insertion into a vagina. The probe 121includes an inflation member or balloon 125 having an outer surface 127.The balloon 125 may be configured to assume a plurality of states ofexpansion between minimum expansion and maximum expansion. According toone embodiment, a first electrode 129 a, a second electrode 129 b, and afirst vibrating element [shown as a Gräfenberg Spot (G-Spot) stimulator133] are disposed on the outer surface of the balloon 125. A secondvibrating element (shown as a clitoral stimulator 141) is shown disposedon the handle 111. An inflation device may be located in the handle 111and configured to cause the balloon 125 to inflate, in turn causing atleast one of the electrodes 129 to press into contact with at least onevaginal wall. Processing electronics 801 may be located in the handle111 and configured to control the current and voltage provided to theelectrodes 129 such that the electrodes 129 cause a contraction of amuscle in communication with an electrode 129. The processingelectronics 801 may also be configured to control at least one aspect ofone or more vibrating elements 133, 141.

According to one embodiment, devices and methods described for toningpelvic floor muscles deliver electrical pulses to stimulate musclecontraction to strengthen the muscles in the area of the pelvic floor.Electrical stimulation causes muscles to contract and releaserepeatedly, thereby strengthening those muscles. Toning and tighteningpelvic floor muscles improves intimate health and may increase the powerand intensity of the female orgasm. Electrical tissue stimulation mayalso provide a pleasurable sensation to the user. While the method anddevice are described for vaginal stimulation and pelvic floor toning, itis contemplated that this device may cause pleasurable sensations to auser or tone pelvic floor muscles via the anus and rectum, in whichcase, references to vagina would be modified accordingly.

Before discussing further details of the devices, it should be notedthat references to “front,” “rear,” “right,” and “left” in thisdescription are merely used to identify the various elements as they areoriented in the FIGURES, with “right,” “left,” “front,” and “rear” beingrelative to a specific direction. These terms are not meant to limit theelement which they describe, as the various elements may be orienteddifferently in various applications.

It should further be noted that for purposes of this disclosure, theterm coupled means the joining of two members directly or indirectly toone another. Such joining may be stationary in nature or moveable innature and/or such joining may allow for the flow of fluids,electricity, electrical signals, or other types of signals orcommunication between the two members. Such joining may be achieved withthe two members or the two members and any additional intermediatemembers being integrally formed as a single unitary body with oneanother or with the two members or the two members and any additionalintermediate members being attached to one another. Such joining may bepermanent in nature or alternatively may be removable or releasable innature.

Referring to FIG. 1, a perspective view of a device 101 is shownaccording to an exemplary embodiment. As described below, device 101 maybe used for causing a pleasurable sensation or toning pelvic floormuscles, specifically in women. According to the exemplary embodimentshown, device 101 includes a housing, shown as handle 111, and a probe121. Handle 111 provides the user a region which may be grasped forcontrol and manipulation of the device 101 and to facilitate insertion,positioning, and removal of probe 121. Handle 111 is shown to include asleeve 113 configured to cover the majority of handle 111. Sleeve 113 ispreferably pliable and provides a smooth and watertight surface tohandle 111 wherein the smooth and watertight surface facilitatescleaning which is beneficial due to the handle's 111 proximity to bodilyfluids and the vaginal opening during use. Sleeve 113 may also betranslucent to allow lights 172, 178 (e.g., lamps, LEDs, displays, etc.)or a display (not shown) on handle 111 to shine through. Sleeve 113allows actuation of control inputs, shown as buttons 174, located belowsleeve 113. Further, sleeve 113 may be customizable, e.g., bearingvarious colors or logos. Preferably, sleeve 113 is formed from siliconerubber.

According to the exemplary embodiment, handle 111 includes a firstportion, shown as interface 115, which includes a plurality of controlinputs (e.g. toggles, switches, an electro-acoustic transducerconfigured to receive voice commands, a touch sensitive display, etc.),shown as buttons 174, configured to enable user input into device 101.For example, button 174 a may be a power button configured to turndevice 101 on and off. Button 174 a may be a combination power/modebutton configured to turn device 101 on and off and to switch betweenoperating states (e.g., vibrational patterns, pleasurable sensationversus muscle toning, etc.). According to the exemplary embodiment,buttons 174 b control the frequency or speed of vibration, and buttons174 c increase or decrease the intensity of the electrical stimulation.According to an alternate embodiments, buttons 174 may provide othercontrol inputs, for example, stimulation select, pressure select,increase, decrease, frequency, amplitude, current, voltage, pause, etc.

According to the embodiment shown, interface 115 includes a plurality ofsequentially oriented lamps 178 (e.g., lights, LEDs, etc.) configured toindicate the level of electrical stimulation intensity. According toother embodiments, lamps 178 may indicate a level of vibrationalintensity or the pressure inside balloon 125. Interface 115 may alsoinclude a display (not shown) configured to numerically indicate balloonpressure, stimulation intensity, or vibrational intensity. The displaymay be further configured to display images, pictures, or videos (e.g.,instructional or erotic images), or to display a waveform representativeof the stimulation signal. The display and the plurality of lamps 178may indicate the same or different information. Interface 115 mayinclude a plurality of indicator lamps 172 (e.g. lights, LEDs, etc.)which may indicate a power state (e.g., power on, battery low, etc.), acommunication state (e.g., communication to a computer, etc.), pressurestate (e.g., the pressure inside balloon 125 has reached a predeterminedvalue), an error state, etc.

According to an alternate embodiment, interface 115 may be located on aseparate control unit. The control unit may be coupled to handle 111 viacable 106 or configured to communicate with device 101 wirelessly, forexample, using Bluetooth, wireless local area network, or personal areanetwork protocols. According to various alternate embodiments, any orall of the components of device 101 may be located on or in the controlunit. For example, lamps 172, 178, control inputs 174, and/or powersupply 809 (e.g., batteries) may be located on the control unit.Alternatively, display 811, audio device 813, processing electronics801, and probe controller circuit 807 may be located in the controlunit. According to another embodiment, pump 511 may be located incontroller 104.

According to the embodiment shown, probe 121 generally has the form ofan elongated cylinder having an open proximal end and a closed distalend. Probe 121 may include a neck portion 123 near the proximal end.Probe 121 includes a member or expandable portion, shown as balloon 125.According to the exemplary embodiment, balloon 125 includes a singleinflatable balloon having an outer surface 127. According to alternateembodiments, the expandable portion may include a plurality of balloons.According to various embodiments, the plurality of balloons may beoriented axially, radially, circumferentially, or some combinationthereof. Balloon 125 may be formed of an airtight, elastic,biocompatible material, such as silicone rubber. According to alternateembodiments, balloon 125 may be formed of any suitable material.

Probe 121 is further shown to include at least one electrode 129, shownas electrode 129 a (e.g., first electrode, top electrode, etc.).Preferably, electrode 129 is mounted to outer surface 127 of balloon 125in such a manner that electrode 129 may come into contact with tissueadjacent to balloon 125 when probe 121 is in an inserted position.Referring briefly to FIG. 2, probe 121 may include a second electrode129 b (e.g., bottom electrode, etc.). First electrode 129 a and secondelectrode 129 b are shown radially opposite one another; however, probe121 may have a plurality of electrodes 129, the plurality of electrodesbeing located anywhere on probe 121, e.g., left and right sides, both ontop, axially or circumferentially offset, or equally or unequally spacedcircumferentially around probe 121. The relative position of theelectrodes 129 is dependent upon the particular tissue to receive theelectrical stimulation. The placement and relative spacing of theelectrodes will determine, in part, the effectiveness of the musclecontraction as a result of the electrical stimulation. According tovarious embodiments, a plurality of electrodes 129 may be energized atthe same time, different electrodes (e.g., a subset of a plurality ofelectrodes) may be actuated during different phases of an exercise orpleasurable sensation session, or different electrodes may be actuatedduring different sessions. For example, an even number of electrodes 129may be actuated in pairs, or an odd number of electrodes may be actuatedin a rotating pattern. Actuating different electrodes 129 at differenttimes may cause different muscles to contract, thereby toning more anddifferent pelvic floor muscles and preventing the muscles from becomingadjusted or de-sensitized to the electrical stimulation. According tovarious embodiments, a user may select which electrodes 129 are actuatedor may select a pattern or actuation of electrodes in order to provide adesired pleasurable sensation. Alternatively, position of electrodes 129may be chosen to facilitate manufacture of balloon 125, for example,aligning electrodes 129 with G-Spot stimulator 133 may simplify molddesign. The plurality of electrodes 129 may have the same or differentshape. Electrode 129 is configured to deliver electrical pulses (e.g.,signals, currents, voltages, frequencies, etc.) to stimulate musclecontraction to strengthen the muscles in the area of the pelvic floor.It is contemplated that the electrical stimulation provided to tonepelvic floor muscles may be different than the optimal stimulation toprovide a pleasurable sensation. Electrode 129 may also communicate aresponse information (e.g., a signal indicative of the contractive forceof the muscles) to processing electronics 801. According to oneembodiment, the response information is a voltage created by thecontracting muscle. According to another embodiment, the responseinformation is an electric potential difference between first electrode129 a and second electrode 129 b. The muscle contraction causing theresponse information may be caused by electrode stimulation of themuscle or may be the result of a manual contraction caused by the user.

According to the exemplary embodiment, electrodes 129 may be formed fromstainless steel, and in another embodiment, the electrodes may be formedfrom an expandable, conductive silicone rubber or any other suitablematerial. It may be desirable to limit electrodes 129 from expanding soas to maintain a relatively consistent conductivity or to prevent themuscle stimulation from moving as balloon 125 is expanded. Further,electrodes formed of materials different than balloon 125 may not expandat the same rate as balloon 125 during inflation. Therefore, it may bebeneficial to provide a balloon 125 which expands non-uniformly.

According to the exemplary embodiment, electrode 129 a is supported by afirst portion of balloon 125. The first portion of balloon 125 and asecond portion of balloon 125 cooperate to cause balloon 125 to expandin a radially and/or circumferentially non-uniform manner relative toprobe 121. Similarly, electrode 129 b is supported by a third portion ofballoon 125. The first and third portions of balloon 125 cooperate tocause balloon 125 to expand in a radially and/or circumferentiallynon-uniform manner relative to probe 121. Non-uniform expansion ofballoon 125 may cause balloon 125 to substantially contour to theanatomy of a user, for example, to conform to the contours of the user'svagina. Non-uniform expansion of balloon 125 may also facilitate asuitable and comfortable fit of balloon 125 for the user.

According to one embodiment, the second portion may be an expansionportion (e.g., folds, pleats, articulation, etc.), shown as bellows 131.The folds of bellows 131 provide a region of increased surface area ofballoon 125 in the deflated state, which allows balloon 125 to expand ina circumferentially non-uniform manner. As shown, bellows 131 extendlongitudinally or axially along the sides of balloon 125. Bellows 131are further shown to extend around the distal end of balloon 125.Accordingly, bellows 131 are shown to extend substantially continuouslyaround the midsection (e.g. equatorially region) of balloon 125.According to various alternate embodiments, bellows 131 may extenddiscontinuously, in a top/bottom meridian formation, or in any suitableorientation to cause differential expansion of balloon 125. Probe 121may include any number of bellows 131 equally or unequally spaced aroundprobe 121. Referring briefly to FIGS. 6 and 7A, bellows 131 may beconfigured to provide an opening 603 through which wires 227 may passwhen balloon 125 is in a deflated state. According to the exemplaryembodiment, bellows 131 are configured such that a majority of theexpansion of balloon 125 occurs in the bellows region.

Referring now to FIG. 7A, a radial cross-section of probe 121 is shownin a first state (e.g., minimum expansion, contracted, deflated, etc.),whereas FIG. 7B shows a radial cross-section of probe 121 in a secondstate (e.g., expanded state, inflated, etc.). As seen in the first,deflated state, bellows 131, first and third portions of balloon 125 areclosely adjacent to or abut shaft 211. However, in the second, orexpanded state, bellows 131 have substantially unfolded allowing radialexpansion of the first and third portions of balloon 125 and electrodes129 a and 129 b provided thereon.

According to another embodiment, the first portion of balloon 125 mayhave a first thickness 605, and the second portion of balloon 125 mayhave a second thickness 607, specifically thickness 605 of the firstportion being greater than thickness 607 of the second portion.Accordingly, the first portion tends to resist circumferential expansionand maintain its form when balloon 125 is inflated. The second portionprovides a “path of least resistance” for expansion, such that for aprescribed level of inflation pressure, balloon 125 will stretch orexpand the material of balloon 125 more in the second region than in thefirst region.

According to one embodiment, at minimum expansion, balloon 125 has adiameter of between approximately 1 inch and approximately 2 inches.Preferably, at minimum expansion, balloon 125 has a diameter ofapproximately 1⅛ inches. According to one embodiment, at maximumexpansion, balloon 125 has a diameter of between approximately 2 inchesand approximately 4 inches, the preferred maximum expansion of balloon125 being between approximately 3 inches and approximately 4 inches indiameter. Expansion of balloon 125 in these ranges enables contouringballoon 125 to women of different anatomical sizes.

Referring to FIGS. 1, 2, and 6, device 101 is shown to have a firstvibrating element, shown as a Gräfenberg Spot or G-Spot stimulator 133,and a second vibrating element, shown as a clitoral stimulator 141.Clitoral stimulator 141 is in the shape of a curved projection or fingerwhich extends outwardly from the outer surface 127 of balloon 125adjacent neck 123 of balloon 125. As shown in the figures, theprojection curves in the distal direction (i.e., away from neck 123 ofballoon 125). G-Spot stimulator 133 is shown as a rounded projection or“bump.” G-Spot stimulator 133 extends a shorter distance outwardly fromthe surface of balloon 125 than clitoral stimulator 141 such that theheight of clitoral stimulator 141 is greater than the height of G-Spotstimulator 133. G-Spot stimulator 133 is located between distal end 213of balloon 125 and clitoral stimulator 141, and clitoral stimulator 141is located between G-Spot stimulator 133 and the proximal end of theballoon. G-Spot stimulator 133 may be used to indicate to a user thatprobe 121 is properly inserted. For example, G-Spot stimulator 133 mayprovide a user a point of reference for internal positioning probe 121.

In the exemplary embodiment shown, G-Spot stimulator 133 includes acavity 503 and clitoral stimulator 141 includes a cavity 535. Cavities503 and 535 are configured to receive vibration actuators 533 and 537,respectively, which are configured to cause vibration of the associatedstimulator. According to an alternate embodiment, cavities 503 and 537may be configured to receive a sensor (e.g., capacitive sensor, pressuresensor, conductivity sensor, etc.), which will be discussed furtherbelow. In another embodiment, electrodes 129 may be positioned along theouter surfaces of G-Spot stimulator 133 and clitoral stimulator 141. Inanother embodiment, device 101 may include a single actuator thatgenerates vibrations which are transmitted to balloon 125, G-Spotstimulator 133 and clitoral stimulator 141.

The first vibrating element is shown coupled or mounted just below theouter surface 127 of balloon 125 near proximal end 215 of balloon 125.Thus, in this embodiment, the material that forms the outer surfaces ofthe first vibrating element is integral or continuous with the materialof balloon 125. The second vibrating element is shown coupled or mountedto flange 201 on handle 111 and is discontinuous with the material ofballoon 125. The material of balloon 125 and the outer surfaces of thefirst and second vibrating elements may be any stretchable or expandablebiocompatible material, and in one embodiment may be silicone rubber.

Referring to FIG. 2, a perspective view of a portion of device 101 isshown with sleeve 113 and balloon 125 removed, according to an exemplaryembodiment. Handle 111 may be formed of a plurality of portions, such asa “clam shell” assembly. As shown, handle 111 includes a left portion203, a right portion 205, and a bottom portion 207, wherein left portion203 and right portion 205 are hollow, substantially symmetric pieces ofABS plastic coupled together to form a housing. In the embodiment shown,left portion 203 and right portion 205 form a structure (e.g., base,support, etc.), shown as flange 201 which is configured to supportclitoral stimulator 141 and to form a passage through which wires 227 cmay pass into handle 111. Bottom portion 207 may include an inflationdevice, wherein bottom portion 207 is formed of a deformable material,for example, a silicone rubber which is sufficiently pliable to compressthe inflation device and to return to shape. According to variousalternate embodiments, bottom portion 207 may be a rigid portion movablycoupled to left portion 203 and/or right portion 205. Left portion 203,right portion 205, and bottom portion 207 may be formed of any suitablematerial, may be formed of the same or different materials, or may beformed as one element. Portions of handle 111 may be coupled by snapfit, fastener, hinge, and/or any other suitable coupling technique.Handle 111 is further shown to include a release valve 209, discussed indetail below, and a plurality of holes 271 configured to receive buttons174 and lamps 172, 178.

According the exemplary embodiment seen in FIGS. 2 and 5-7B, device 101includes a shaft 211 configured to house batteries used to power device101 or components thereof. As shown, shaft 211 is an elongated structurehaving a distal end 213 and a proximal end 215, the proximal end 215being coupled to handle 111. According to an alternate embodiment, shaft211 may be interconnected to a remote control unit via a cable. Shaft211 may include an operative region 217 located between proximal end 215and distal end 213, the operative region 217 being configured to besubstantially located within the vagina when probe 121 is in an insertedposition. Shaft 211 may be solid, hollow, or any combination thereof.

As shown, shaft 211 includes a radially extending flange (e.g., collar),shown as bulkhead 219. Bulkhead 219 is configured to provide asubstantially airtight seal between handle 111 and balloon 125.According to the exemplary embodiment, bulkhead 219 includes a firstpassage, shown as bottom passage 221, and a second passage, shown as toppassage 225. Bottom passage 221 may be configured to allow a conduit,shown as tube 223, to extend from an inflation device into balloon 125.A substantially airtight seal is preferably formed (e.g., with siliconeglue) between tube 223 and bulkhead 219. Top passage 225 may beconfigured to allow wires 227 to pass from electrodes 129 and/or othersensors or motors into handle 111. As shown, wires 227 a couple toelectrodes 129, and wires 227 b couple to G-Spot vibration actuator 533.A substantially airtight seal may be formed (e.g., with silicone glue)between wires 227 and bulkhead 219. Bulkhead 219 may have any number ofpassages, and the passages may have any orientation around shaft 211.Alternatively, bulkhead 219 may include one passage for passing bothtube 223 and wires 227.

According to alternate embodiments, tube 223 and/or wires 227 may berouted through shaft 211. Shaft 211 may include perforations configuredto allow pressurizing fluid pumped through shaft 211 to enter intoballoon 125. Routing pressurizing fluid, tube 223, and/or wires 227through shaft 211 may eliminate the need for passages 221, 225 throughbulkhead 219. Accordingly, these passages may be removed in order toimprove the airtight seal between handle 111 and balloon 125.

Referring to FIGS. 3 and 4, a bottom view and a top view, respectively,of device 101 are shown according to an exemplary embodiment. Handle 111includes a battery cap 303 configured to retain batteries 541 withinshaft 211. As shown, battery cap 303 cap forms an end portion of shaft211. According to alternate embodiments, battery cap 303 may beconfigured to allow wires 227 to pass out of handle 111, for example, toa power outlet or to a remote control unit. Handle 111 is further shownto include structure such as air inlet 305 (or orifice, valve, grommet,etc.) for inflation of balloon 125 described further below.

The diameter of balloon 125 may be substantially uniform over the lengthof probe 121, or the diameter of balloon 125 may vary. As shown,proximal end 215 of balloon 125 has a first diameter, and distal end ofballoon 125 has a second diameter, the second diameter being greaterthan the first diameter. According to one embodiment, probe 121transitions from the first diameter to the second diameter between neckportion 123 and electrode 129. According to the embodiment shown inFIGS. 3 and 6, balloon 125 begins to transition from the first diameterto the second diameter proximate G-Spot stimulator 133. Varying thediameter of balloon 125 along the length of probe 121 effects theexpansion of balloon 125 along the length of probe 121. For example, thesmaller proximal diameter limits expansion at proximal end 215 whileallowing greater expansion of balloon 125 near electrodes 129 andproximal end 212, thereby contouring balloon 125 to the vaginal cavity.This further enables electrodes 129 to press against vaginal wallswithout applying excessive pressure on the introitus (vaginal entrance).

Referring to FIG. 5, a partially exploded view of device 101 is shownwith tube 223 and wires 227 removed for clarity, according to anexemplary embodiment. As shown, balloon 125 includes a depression,cavity, or pocket 403 configured to receive electrode 129. According toan exemplary embodiment, a periphery of electrode 129 is configured toseat into pocket 403, and a sealant (e.g., silicone glue) may be used tocouple electrode 129 to pocket 403 and to form a substantially airtightseal between electrode 129 and balloon 125. Forming a seal between anouter periphery of electrode 129 and balloon 125 achieves the addedbenefit of preventing fluid or debris from getting underneath electrode129, thereby facilitating sanitary maintenance of probe 121. Balloon 125is further shown to include an aperture, shown as hole 405, which isconfigured to permit passage of wires 227 from electrode 129 to theinterior of balloon 125. A sealant may be used to retain wires 227 inplace and to form a substantially airtight seal between wires 227 andballoon 125.

According to the embodiment shown, probe 121 comprises only one balloon125 configured to surround operative region 217 of shaft 211. Referringbriefly to FIG. 12, singular balloon 125 is shown to surround the entireportion of shaft 211 located within a vagina 21 when probe 121 is in aninserted position. FIG. 12 schematically depicts an embodiment of thedevice depicted and generally described in relation to FIGS. 1-11. Thevibration element 141 extends to a point in which it abuts or is incontact with the clitoris or the surrounding tissue. According tovarious embodiments, probe 121 is in an inserted position whenelectrodes 129 are located within the vagina 21 or when G-Spotstimulator 133 is proximate a user's Gräfenberg Spot (G-Spot) 23. Use ofa single balloon has the benefit of minimizing costs (assembly andmaterial) while also simplifying the structure of the device.

According to the exemplary embodiment, device 101 includes a printedcircuit board 407 configured to be supported by left portion 203 andright portion 205 of handle 111. As shown, circuit board 407 isconfigured to support lamps 172, 178, input controls 174, and processingelectronic 801. A power supply 809 may be coupled to circuit board 407and batteries 541.

Referring to FIG. 6, a longitudinal cross-section of device 101 is shownaccording to an exemplary embodiment. Balloon 125 is shown to define alumen or cavity 531, and cavity 531 is configured to receive shaft 211.Balloon 125 is shown to circumferentially surround at least a portion ofshaft 211.

Probe assembly 102 is shown to include an inflation device located atleast partially within bottom portion 207 of handle 111 for selectivelyinflating and deflating balloon 125. According to an exemplaryembodiment, the inflation device includes a pump 511 which may bemanually operated. Pump 511 includes a cavity within bottom portion 207,shown as bladder 513, and a first check valve 515 is located betweenbladder 513 and air inlet 305. Check valve 515 permits air to enterbladder 513 through air inlet 305 from outside of device 101 andprevents air from exiting back through air inlet 305 when bladder 513 iscompressed. A second check valve 517 is located between tee connector519 and bladder 513. Check valve 517 permits air to enter tee connector519 from bladder 513 and prevents air from back flowing into bladder513, for example, when bladder 513 expands.

As shown, tee connector 519 couples bladder 513, release valve 209, andtube 223. Release valve 209 may be of any suitable mechanism to permitair under pressure to be selectively released from balloon 125, forexample a thumbscrew or a pushbutton. Release valve 209 may also act asa relief valve to prevent over-pressurization of balloon 125. Tube 223extends from an outlet of tee connector 519 through bulkhead 219 intoprobe 121. In operation, squeezing bottom portion 207 compresses bladder513 and forces air through tee connector 519 and tube 223 into balloon125. When the squeezing force exerted on bladder 513 is released,bladder 513 will resume its natural, inflated position as air is drawninto bladder 513 through check valve 515. Bladder 513 is squeezed andreleased repeatedly to force pressurized air into balloon 125. Increasedpressure in balloon 125 eventually causes inflation of balloon 125,which in turn causes electrode 129 to contact a vaginal wall. Accordingto one embodiment, the level of inflation of balloon 125 is controlledby a user and may be selected to ensure a suitable and comfortable fitbetween balloon 125 and the user's vagina. According to anotherembodiment, the preferred level of inflation is stored in memory 921 ofprocessing electronics 801 described below. According to variousalternate embodiments, the inflation device may include a motorizedpump, the inflation device may be located in a remote control unit andpressurized air directed into balloon 125 through flexible tubing,and/or the inflation device may be located within probe 121. Asdescribed, the pressurizing fluid of the exemplary embodiment is air;however, any suitable pressurizing fluid may be used, for example,water, saline, oil, or other gases or liquids.

According to various alternate embodiments, device 101 includes apressure sensor barometrically connected to balloon 125 and located inprobe 121 (e.g., in cavity 503), in handle 111, or in the control unit.The pressure sensor may visually display an indication of a pressureinside balloon 125 on handle 111, for example, a gauge, a light, adigital display, etc. Providing an indication of pressure enables a userto determine a preferred pressure and to repeatably return to thatpressure. The pressure sensor may be configured to communicate (viawires or wirelessly) pressure information to processing electronics 801.For example, the pressure sensor may generate a response information(e.g., a signal indicative of the rise in pressure caused by contractiveforce of the muscles on balloon 125) triggered by the electricalstimulation provided by electrodes 129 or by the user manually (e.g.,consciously, volitionally, voluntarily, etc.) forcing a contraction ofher pelvic floor muscles. Tracking response information enables a userto determine progress in pelvic floor muscle toning.

According to an exemplary embodiment, neck portion 123 of probe 121includes an external annular groove 523 and an internal annular groove525. Internal annular groove 525 is configured to fit over a radialperiphery of bulkhead 219, and a sealant (e.g., silicone glue) may beused between internal annular groove 525 and bulkhead 219 to form asubstantially airtight seal. Proximate bulkhead 219, left handle portion203 and right handle portion 205 cooperate to form a substantiallycylindrical portion 527 and an inwardly extending annular flange 529.Substantially cylindrical portion 527 fits over neck portion 123 ofprobe 121 and helps to hold internal annular groove 525 against bulkhead219. Inwardly extending flange 529 fits into external annular groove 523of probe 121. Accordingly, neck portion 123 and handle 111 areconfigured to prevent balloon 125 from slipping free of handle 111.

Referring to FIGS. 7A and 7B, shaft 211 is shown to be axially locatedwithin cavity 531 of probe 121. According to the exemplary embodiment,shaft 211 is configured to provide sufficient rigidity to probe 121 tofacilitate insertion of probe 121 into a vagina. Shaft 211 may include aplurality of portions (e.g., members, structures, regions, webs, etc.),shown as ribs 611, configured to support balloon 125. Ribs 611 a maysupport bellows 131 and inhibit bellows 131 from collapsing into cavity531. Balloon 125 may include a plurality of structures (stiffeners,portions, etc.), shown as lugs 613, which are shown to rest on ribs 611b when balloon 125 is in a fully deflated state. Lugs 613 providecushioning between shaft 211 and a user. Lugs 613 may also stiffenportions of balloon 125 underneath electrodes 129, thereby reducingflexure of balloon 125 in the area of the electrode. As shown, bellows131, lugs 613 and ribs 611 are configured to cooperate to maintain asubstantially round shape to probe 121 when balloon 125 is in a deflatedstate.

Operation of device 101 is described below according to an exemplaryembodiment. A method for toning pelvic floor muscles in a femaleincludes inserting probe 121 into the vagina, pressurizing balloon 125to inflate balloon 125 such that electrodes 129 contact the walls of thevagina (e.g., to place electrodes 129 snugly against the walls of thevagina to provide an electrical conduction pathway from the electrodesto the muscles and/or associated nerves), and periodically supplying apulsed electrical stimulation to electrodes 129 to stimulate themuscles. In this manner, balloon 125 allows device 101 to ensure aproper fit with anatomies of different sizes. As the muscles contract inresponse to the electrical stimulation, the walls of the vagina exert aforce on inflated balloon 125, and as the muscles contract, balloon 125is compressed. Device 101 may include a pressure sensor configured togenerate a signal indicative of the contractive force of the muscles onballoon 125 triggered by the electrical stimulation provided through theelectrodes 129. The signal from the pressure sensor may be communicated(e.g., via wired or wireless connections) to processing electronics 801.Processing electronics 801 may be configured to process the signal fromthe pressure sensor to determine information related to musclecontraction caused by the electrical stimulation (e.g., the force orstrength of muscle contraction, the duration of muscle contraction,etc.). When muscle contraction stops, the air pressure within balloon125 causes balloon 125 to expand to original inflated size. The methodalso includes using a biphasic pulse. The progress of the toningexercises can be monitored by evaluating the increase in strength ofmuscle activity by measuring muscle contraction over a number ofexercise sessions. Toning exercises may be particularly useful for womenwho have recently given birth. According to one embodiment, device 101may be used three weeks after childbirth. A method for causing apleasurable sensation in a user may include similar steps as well as thesteps of causing the vibration of clitoral and/or G-Spot stimulators.The pleasurable sensation may be used to cause an orgasm, which in turncauses a release of serotonin and norepinephrine in the user which mayimprove the user's mood and treat depression, specifically post-partumdepression.

According to the exemplary embodiment described, processing electronics801 supply a biphasic pulse of electrical current to electrodes 129which in turn stimulates contraction of the muscles. For example, thebiphasic pulse may have a first stimulation phase providing a pulse at12 hertz for 6 seconds followed by a first rest period having a durationof 6 seconds. A second stimulation phase providing a pulse at 25 hertzfor six seconds follows the first rest period, and a second rest periodhaving a duration of 6 seconds follows the second phase. The use of abiphasic pulse (e.g., a pulse having two stimulation periods havingdifferent frequencies) prevents the muscles from becoming adjusted orde-sensitized to the electrical stimulation. In another embodiment, amultiphasic pulse (e.g., a plurality of different pulse durations and/orfrequency between pulses) may be used. This sequence of stimulationphases and rest phases repeats for a treatment period as necessary. Atypical treatment period is approximately 15 minutes. In otherembodiments, other frequencies and/or durations for the stimulationphases and/or rest periods may be used. For example, in one embodiment,the frequency delivered may be variable, and frequencies up to 50 hertzmay be delivered. Within each stimulation phase, a symmetric alternatingcurrent may be applied to the muscle via electrodes 129 to reduce theeffects of electrophoresis or cataphoresis on the muscle tissues. Forexample, applying a current of a positive first value for a firstpulsewidth (e.g., 200 microseconds), applying no current for 40microseconds, and then applying a current of a negative first value fora first value (e.g., 200 microseconds) limits the migration of ions withthe muscle tissue. This pattern of alternating current pulsewidths maythen be repeated at various frequencies (hertz), e.g., 12 hertz, 25hertz, 50 hertz, etc. Accordingly, the amount of time between the end ofthe negative current until the beginning of the positive current dependson the frequency. Placing a short rest period (e.g., 40 microseconds)between the bipolar phases may improve circuit reliability.

In the embodiment shown, device 101 may be operated at five differentlevels of electrical stimulation. In one embodiment, the lowest level ofelectrical stimulation corresponds to an electrical stimulation currentof 10 milliamps, with each subsequent level increasing the electricalstimulation by 10 milliamps such that the second through fifth levelscorrespond to 20, 30, 40, and 50 milliamps, respectively. In thisembodiment, five lamps 178 are illuminated to correspond with thecurrent operating level of the corresponding stimulation element, andthe electrical stimulation current is delivered in a series ofelectrical stimulation phases separated by rest periods as discussedabove. According to another embodiment, electronics 801 supply abiphasic pulse of electrical potential between electrodes 129. Theelectrical potential between electrodes 129 may have five differentlevels ranging between 10 Volts and 60 Volts. According to anotherembodiment, stimulation may occur as low as 4-5 Volts. Contraction ofthe muscle is a function of current (or voltage) amplitude, pulsewidth,and frequency applied to the muscle. Further, the rate at which themuscle relaxes has a minimum persistence time that is affected by thestrength and duration of the contraction. If the period (i.e.,1/frequency) of stimulation is greater than the minimum persistence timeof the contraction, a user may perceive the stimulation as convulsionsrather than a continuous contraction. Accordingly, processingelectronics 801 may be configured to control one of frequency,pulsewidth, and amplitude in order to maintain a contraction perceivedby the user as substantially continuous. According to one embodiment,processing electronics 801 may be configured to control one offrequency, pulsewidth, and amplitude based on the other two in order tomaintain a substantially continuous contraction. Additionally,processing electronics 801 may be configured to ramp at least one offrequency, amplitude, and pulsewidth at the beginning and/or end of eachphase. Ramping the frequency, amplitude, and/or pulsewidth may reducethe step function of stimulation entering a phase, which may beuncomfortable or startling for some users. According to one embodiment,the pulsewidth may be stepped up by a fraction of the desired pulsewidth(e.g., 50 microseconds) per cycle until the desired pulsewidth (e.g.,200 microseconds) is reached. Processing electronics 801 may inhibitcertain combinations of frequency, current, and voltage. It is believedthat these ranges of currents and voltages provide stimulative andtoning benefits. In various embodiments, the user, via a control 174located on a remote control unit, may control the frequency of theelectrical signal being supplied, may control the current deliveredduring each stimulation phase, or may control the voltage deliveredduring each stimulation phase.

Device 101 may also be operated at multiple, different levels ofvibration stimulation intensity. In one embodiment, the user may controlthe amplitude of vibration generated by the first and second vibratingelements 133, 141 to five different levels, and, in another embodiment,the user may control the frequency of vibration generated by the firstand second vibrating elements 133, 141 to five different levels. In thisembodiment, indication of vibration level is provided haptically to theuser (i.e., the user can feel the level of vibration); however,according to other embodiments, five lamps 178 may be illuminated tocorrespond with the present operating level of the correspondingvibrating element 133, 141. In the embodiment shown, the first andsecond vibrating actuators 533, 537 may be controlled independently ofeach other, and, in this embodiment, interface 115 may include a firstpair of vibration control buttons 174 that control vibrations of thefirst vibrating element 133 and a second pair of vibration controlbuttons 174 that control the vibration of the second vibrating element141. In another embodiment, both the first vibrating actuator 533 andthe second vibrating actuator 537 are controlled together based upon thevibration level selected by the user by interacting with the vibrationcontrol buttons 174.

In the exemplary embodiment described, the level of stimulation and thelevel of vibration are controllable independently and separately fromeach other via interaction with the independent stimulation andvibration control buttons 174 as discussed above. In another embodiment,the level of electrical stimulation and the level of vibration arecontrollable together such that the user can decrease and increase thelevel of electrical stimulation and the level of vibration together viainteraction with a single set of controls.

According to an alternate embodiment, stimulation device 101 may be onecomponent of a stimulation device system that also includes a handhelddisplay device. The handheld display device includes a display screenand a set of display device controls. The handheld display device may beconfigured to display exciting or erotic material (e.g., videos,pictures, etc.) which may be viewed by the user while using thestimulation device. In one embodiment, the handheld display device mayinclude wireless communication hardware and/or wired communicationshardware that allows the material to be downloaded from a source (e.g.,the internet, a proprietary server, another local computer, etc.). Inone embodiment, the handheld display device may include a local memorydevice which stores the material to be displayed once it is downloaded.The handheld display device may also be configured to stream thematerial directly from the source. The user may control the display ofthe material (e.g., play, pause, rewind, fast-forward, etc.) via thedisplay device controls.

In one embodiment, the handheld display device may be configured tocommunicate with the processing electronics 801 of the stimulationdevice via a communication link or connection. In one embodiment, theoperation of the stimulation device 101 may be controlled based upon anaspect or property of the material displayed on the display device. Insuch embodiments, the processing electronics 801 may receive a signalfrom the handheld display device that provides information related tothe aspect of the material being displayed, and the electronic controlunit is configured to adjust the level of electrical and/or vibrationstimulation based upon the provided information. For example, the levelof electrical and/or vibration stimulation delivered by the stimulationdevice may be altered based on the nature of a scene of the video beingdisplayed.

In another embodiment, the operation of the display device may becontrolled based upon operation of the stimulation device 101. In suchembodiments, a signal indicative of an operating parameter of thestimulation device 101 may be communicated to the display device, andthe operation of the display device may be controlled based upon theoperating parameter. For example, in one embodiment, when thestimulation device 101 is powered on, a corresponding signal may betransmitted to the display device causing the display device to poweron. As another example, if the stimulation device is on and the displaydevice is on and playing a video, turning the stimulation device off bypressing the power button on the electronic control unit may trigger asignal to be generated to the display device which causes the video tobe paused.

Referring to FIG. 8, a block diagram of device 101 is shown according toan exemplary embodiment. Device 101 is shown to include a pump 511,electrode 129, sensors 803, and vibrating elements 805. Pump 511 isconfigured to cause inflation of balloon 125 and may be manuallyoperated or motorized. First electrode 129 a and/or second electrode 129b are configured to provide an electrical signal (e.g., current,voltage, frequency, etc.) to a muscle in communication with theelectrode. According to various embodiments, device 101 may have one ora plurality of electrodes 129 and may include one or more sensors 803(e.g., a capacitive sensor, a pressure sensor, a conductivity sensor,etc.). Sensors 803 may be disposed in any suitable location in device101 (e.g., in handle 111, in cavity 503 under G-Spot stimulator 133,etc.). Vibrating elements 805 (e.g., G-Spot stimulator 133, clitoralstimulator 141, actuation motors 533, 537, etc.) may each have avibrating motor or may share a vibrating motor, and may be configured toprovide a pleasurable sensation to a user or to provide haptic feedbackto a user, the haptic feedback being in response to user input throughcontrols 174 or as an indication that balloon 125 has been inflated to apredetermined pressure. The pleasurable sensation may induce a user tomaintain compliance with an exercise regimen.

According to an exemplary embodiment, device 101 is shown to includecontrol inputs 174, lamps 178, 172, display 811, audio device 813,processing electronics 801, probe controller circuit 807, and powersupply 809. The control inputs may include any suitable user interface,e.g., buttons 174, toggles, switches, an electro-acoustic transducerconfigured to receive voice commands, a touch sensitive display, etc.Lamps such as lamps 178, 172 may provide information to a user throughillumination, brightness, color, blinking pattern, and/or illuminationof a subset of a plurality of spatially oriented lamps. Display 811 mayalso be configured to provide alphanumeric or graphical images and mayinclude a touchscreen (e.g., touch sensitive surface), the touchscreenbeing configured to both provide information to a user and to receiveinput from a user. Using a touchscreen would provide an easy to cleansurface, thereby facilitating sanitary hygiene. Audio device 813 may bea speaker configured to provide aural information to a user and may becombined with or separate from the electro-acoustic transducer controlinput. Audio device 813 may be configured to provide motivation and/oraudio instruction to a user, to announce that the pressure insideballoon 125 has reached a predetermined level, or to request a user tomanually force a contraction of the muscle in communication withelectrodes 129. Probe controller circuit 807 may include any number ofmechanical or electrical circuitry components or modules for a pump 511,electrode 129, sensors 803, and/or vibrating elements 805 of device 101.For example, circuit 807 may be configured to send electrical signals topelvic floor muscles while sending response information to processingelectronics 801.

Device 101 is further shown to include a power supply 809. Power supply809 is configured to provide electrical power to device 101 andcomponents thereof. According to an exemplary embodiment, device 101 isconfigured to be powered by a 6 Volt source (e.g. four AA batterieslocated in shaft 211 or a 6-Volt battery). According to otherembodiments, device 101 may use other voltages, a rechargeable battery,or may be plugged into utility power supply. Power supply 809 orprocessing electronics 801 may be configured to increase the voltageand/or amperage available to electrodes 129. According to oneembodiment, the maximum electrical potential generated between the firstelectrode 129 a and second electrode 129 b is approximately 80 Volts.According to another embodiment, it is believed that the maximumtherapeutic range of the electrical potential generated between firstelectrode 129 a and second electrode 129 b is approximately 50 Volts.According to the exemplary embodiment, power supply 809 and/orprocessing electronics 801 are configured to provide power to 3-Voltmotors used in vibrating elements 805.

Referring to FIG. 9, a detailed block diagram of processing electronics801 of FIG. 8 is shown, according to an exemplary embodiment. Processingelectronics 801 includes a processor 911 and a memory 921. According toan exemplary embodiment, processor 911 is configured to execute computercode stored in memory 921 to complete and facilitate the activitiesdescribed herein. For example, memory 921 is shown to include modules923-941 which are computer code modules (e.g., executable code, objectcode, source code, script code, machine code, etc.) configured forexecution by processor 911. When executed by processor 911, processingelectronics 801 is configured to complete the activities describedherein. Processing electronics includes hardware circuitry forsupporting the execution of the computer code of modules 923-941. Forexample, processing electronics 801 includes hardware interfaces (e.g.,output 951) for communicating control signals (e.g., analog, digital)from processing electronics 801 to circuit 807. Processing electronics801 may also include an input 956 for receiving, for example, sensordata from circuit 807, response information from circuit 807, userinputs from control inputs 174, or for receiving data or signals fromother systems or devices. According to various embodiments, processor911 may be or include one or more microprocessors, an applicationspecific integrated circuit (ASIC), a circuit containing one or moreprocessing components, a group of distributed processing components,circuitry for supporting a microprocessor, or other hardware configuredfor processing. Memory 921 can be any volatile or non-volatile memorydevice capable of storing data or computer code relating to theactivities described herein.

Memory 921 includes a memory buffer 923 for receiving sensor data, forexample response information, pressure data, voltage data, capacitivesensing data, conductivity data, etc. The sensor data may be stored inmemory buffer 923 until buffer 923 is accessed for data. For example, aprogram module 929, electrode module 931, vibration 933, conductivitymodule 935, inflation module 937, position module 939, pressure module941, or another process that uses sensor data may access buffer 923. Thesensor data stored in memory 921 may be stored according to a variety ofschemes or formats. For example, the sensor data may be stored asstreaming data, peak values, synchronous, asynchronous, separate buffersfor each data type, one buffer for all sensor data, or any othersuitable format for storing sensor information.

Memory 921 further includes configuration data 925. Configuration data925 includes data relating to device 101, such as electrode informationthat the electrode module 931 can interpret to determine how to commandthe electrodes 129 to cause a muscle contraction, for example the numberof electrodes, electrode conductivity, conductivity as a function ofexpansion or pressure, etc. According to another embodiment,configuration data 925 may include pump information, such as whether thepump 511 is hand-operated or motorized, and control information of themotorized pump. According to another embodiment, configuration data 925may include sensor information, such as the existence, location, andcalibration of pressure sensors, conductivity sensors, capacitivesensors, and the like. According to another embodiment, configurationdata 925 may include response information configuration data whichprogram module 929 can interpret to determine if the responseinformation will include an electrical signal received from at least oneof the electrodes 129, a pressure signal received from a pressuresensor, or both.

Memory 921 further includes a program data 927 which includes datarelating to the toning program or stimulation program. Program data 927may include data that program module 929 can interpret to determine howto command the electrical signal sent to electrodes 129. For example,program data 927 may include electrical stimulation data including datarelating to current, voltage, frequency, number of phases of stimulationsignal, duration and pattern of stimulation periods, and/or duration andpattern of rest periods. Program data 927 may include vibrationalstimulation data including data relating to vibration, frequency,pattern, etc. Program data 927 may be stored in memory 921 by the useror another, may be downloaded into memory 921, and may be synchronizedwith audio or video files.

Memory 921 further includes a program module 929 which includes logicfor using configuration data 925, program data 927, sensor data from thememory buffer 923, and/or data received from another module to carry outthe pleasurable sensations or muscle toning program, e.g., providingstimulation commands to electrode module 931 or vibration module 933.Program module 929 may output data to a data logging module forrecording, may cause outputs for providing an indication to a user, andmay cause an output requesting a user to perform an activity (e.g.,inserting probe 121, pressurizing balloon 125, forcing a contraction,etc.). Program module 929 may include logic to cause closed-loop controlof the electrical stimulation and/or vibrational stimulation based onresponse information received from memory buffer 923, electrode module931, conductivity module 935, and/or pressure module 941.

Memory 921 further includes an electrode module 931 which includes logicfor causing a contraction of a muscle in communication with electrode129. Electrode module 931 may control the stimulation of a muscle incommunication with electrodes 129 based on conductivity informationreceived from conductivity module 935, position information receivedfrom position module 939, and/or pressure information received frompressure module 941. Electrode module 931 may include logic to controlthe current or voltage provided by electrodes 129 as a function offrequency, or to control the frequency in response to the current orvoltage. According to the exemplary embodiment, electrode module 931 maybe configured to operate at five levels of stimulation, which may beindicated to a user using the five lamps 178 shown on interface 115.According to an alternate embodiment, electrode module 931 may includelogic to use an 8-bit register to control the frequency, current, orvoltage of the stimulation. Using an 8-bit register provides fineresolution for precise stimulation effects and toning.

Memory 921 further includes a vibration module 933 which includes logicfor causing a vibrating element to vibrate. Vibration module 933 mayinclude logic for actuating G-Spot vibration actuator 533, clitoralvibration actuator 537, and a haptic feedback motor. For example,actuators 533 and 537 may be actuated dependently or independently andmay be actuated in response to user input through controls 174, inresponse to response information, or synchronized with music or video.Vibration module 933 may operate actuators 533 and 537 at five differentlevels of vibration. Vibration module 933 may receive data from memorybuffer 923, program data 927, and program module 929.

Memory 921 is shown to include a conductivity module 935 which includeslogic for determining the conductivity of the environment of probe 121,balloon 125, and/or electrodes 129. Conductivity of the environment isdependent on many factors. For example, conductivity may depend on theconductivity and quantity of artificial lubricants used, the quantity ofvaginal fluid present, which may change from day to day or during use,and/or the expansion of electrodes 129. A conductivity sensor in probe121 may measure the resistivity between electrodes 129 or measure thecurrent delivered for a provided voltage. According to one embodiment, alow voltage (e.g., 2 Volts) may be provided across electrodes 129, theresulting current is measured, and resistance is calculated. The lowvoltage may be provided before beginning a toning or exercise program ormay be provided during a portion of a rest period (e.g., betweenphases). Conductivity module 935 may receive sensor data directly orthrough memory buffer 923. Conductivity module 935 may provideconductivity information to electrode module 931 or any other modulerequiring conductivity information.

Memory 921 is shown to include an inflation module 937 which includeslogic for providing an indication to a user that the pressure insideballoon 125 has reached a predetermined value. According to oneembodiment, the predetermined value is a pressure stored in program data927. Inflation module 937 may use sensor data from memory buffer 923 orpressure information from pressure module 941. Inflation module 937 mayinclude logic for causing inflation of balloon 125. For example,inflation module 937 may cause a request for a user to actuate pump 511or may cause actuation of a motorized pump 511. Inflation module 937 maycontrol pump 511 using configuration data 925 and pressure data receivedfrom memory buffer 923 or pressure module 941.

Memory 921 is shown to include a position module 939 which includeslogic for determining if probe 121 is inserted and/or properlypositioned. According to one embodiment, position module 939 may receivecapacitive sensor data from memory buffer 923. According to analternative embodiment, position module 939 may determine insertion ofprobe 121 from a change in continuity or a change in resistance betweenelectrodes 129. According to another alternative embodiment, positionmodule 939 may request user confirmation that probe 121 and/or balloon125 are inserted, for example, by providing input via control inputs 174on controller 104. Position module 939 may cause output from electrodemodule 931 to be inhibited if position module 939 determines thatballoon 125 has been removed from the vagina. For example, positionmodule 939 may cause electrodes 129 to stop providing an electricsignal, or position module 939 may provide position information toprogram module 929 or to electrode module 931.

Memory 921 further includes a pressure module 941 which includes logicfor determining the pressure inside balloon 125. Pressure module 941 mayuse configuration data 925, pressure data received directly from thepressure sensor, or pressure data received from memory buffer 923.Pressure module 941 may provide pressure information to inflation module937 and program module 929. Pressure module 941 may provide pressureinformation to electrode module 931, or may inhibit processingelectronics 801 from causing a contraction of the muscle if the pressurein balloon 125 is below a threshold value, e.g., balloon 125 has notbeen sufficiently inflated. Pressure module 941 may receive responseinformation from the pressure sensor.

Referring to FIG. 11, a flowchart of a process 1001 for toning pelvicfloor muscles is shown according to an exemplary embodiment. Process1001 is shown to include the steps of providing a device as describedabove and including an expandable portion having an outer surface, afirst electrode, and a second electrode (step 1003). Process 1001further includes the steps of causing the expandable portion to inflatesuch that the first and second electrodes contact vaginal walls (step1003), and causing a contraction of the muscle in communication with theelectrodes (step 1007). Process 1001 further includes causing avibrating element to impart vibration to a first potion of a user's body(step 1009). According to one embodiment, the first and secondelectrodes couple to the outer surface of the expandable portion and areconfigured to cause a contraction of a muscle and communication with theelectrodes. According to alternate embodiments, process 1001 may includeadditional or fewer steps. For example, process 1001 may includeinserting the expandable portion in a vaginal cavity, deflating theexpandable portion, and removing the probe from the vaginal cavity andmay not include causing a vibrating element to impart vibration (step1009).

Referring to FIG. 11, a flowchart of process 1101 for toning pelvicfloor muscles is shown according to an exemplary embodiment. Process1101 is shown to include the steps of providing a device as describedabove and including a balloon having an outer surface, a firstelectrode, and a second electrode (step 1103) and inserting the ballooninto a vaginal cavity (step 1105). Process 1101 further includes thesteps of causing inflation of the balloon such that at least one of thefirst and second electrodes press against at least one vaginal wall(step 1107) and causing the balloon to inflate in a radially non-uniformmanner (step 1109). According to various embodiments, step 1107 mayinclude requesting a user to actuate pump 511, causing actuation of pump511, and/or causing operation of a motorized pump. Step 1109 may includeunfolding of bellows or non-uniform expansion of balloon portions havingdifferent thicknesses. Process 1101 is shown to include the steps ofproviding a pattern of at least one of current, voltage, and frequency(step 1111), causing a contraction of a muscle in communication with theelectrodes (step 1113), causing a first vibrating element to impartvibration to a first portion of a user's body (step 1115), and causing asecond vibrating element to impart vibration to a second portion of auser's body (step 1117). Providing the pattern in step 1111 may or maynot cause the contraction or vibrations in steps 1113-1117, and thecontraction and vibrations in steps 1113-1117 may be caused by the sameor different electrical signals. Causing a contraction of a muscle instep 1113 may be through electrical stimulation via electrodes 129 ormay be requesting a user to manually or volitionally force a contractionof the muscle. The balloon may then be deflated (step 1119) and removedfrom the vaginal cavity (step 1121).

Various alternate embodiments of the process described are contemplated.For example, the order of steps may be changed, e.g., causing acontraction of a muscle (step 1113), causing a first vibrating elementto impart vibration (step 1115), and causing a second vibrating elementto impart vibration (1117) may occur in any order, may occursimultaneously, or may occur repeatedly. Process 1101 may not includeall of the steps listed, e.g., not include causing first or secondvibrating elements to impart vibration (steps 1115 and 1117). Process1101 may include additional steps, e.g., lubricating the balloon orrequesting insertion of the balloon into a vaginal cavity, for example,by indicating that device 101 is initialized and ready for insertion(e.g., illuminating in indicator lamp 172), providing an aural requestthrough speaker audio device 813, or providing instructions along withproviding device 101.

It is also important to note that the construction and arrangement ofthe elements of the devices as shown in the exemplary embodiments areillustrative only. Although only a few embodiments of the presentdisclosure have been described in detail, those skilled in the art whoreview this disclosure will readily appreciate that many modificationsare possible (e.g., variations in sizes, dimensions, structures, shapesand proportions of the various elements, values of parameters, mountingarrangements, use of materials, colors, orientations, etc.) withoutmaterially departing from the novel teachings and advantages of thesubject matter recited. For example, elements shown as integrally formedmay be constructed of multiple parts or elements. It should be notedthat the elements and/or assemblies described herein may be constructedfrom any of a wide variety of materials that provide sufficient strengthor durability, in any of a wide variety of colors, textures, andcombinations. Additionally, in the subject description, the word“exemplary” is used to mean serving as an example, instance orillustration. Any embodiment or design described herein as “exemplary”is not necessarily to be construed as preferred or advantageous overother embodiments or designs. Rather, use of the word exemplary isintended to present concepts in a concrete manner. Accordingly, all suchmodifications are intended to be included within the scope of thepresent inventions. Other substitutions, modifications, changes, andomissions may be made in the design, operating conditions, andarrangement of the preferred and other exemplary embodiments withoutdeparting from the spirit of the appended claims. Anymeans-plus-function clause is intended to cover the structures describedherein as performing the recited function and not only structuralequivalents but also equivalent structures.

The present disclosure contemplates methods, systems and programproducts on any machine-readable media for accomplishing variousoperations. The embodiments of the present disclosure may be implementedusing existing computer processors, or by a special purpose computerprocessor for an appropriate system, incorporated for this or anotherpurpose, or by a hardwired system. Embodiments within the scope of thepresent disclosure include program products comprising machine-readablemedia for carrying or having machine-executable instructions or datastructures stored thereon. Such machine-readable media can be anyavailable media that can be accessed by a general purpose or specialpurpose computer or other machine with a processor. By way of example,such machine-readable media can comprise RAM, ROM, EPROM, EEPROM, CD-ROMor other optical disk storage, magnetic disk storage or other magneticstorage devices, or any other medium which can be used to carry or storedesired program code in the form of machine-executable instructions ordata structures and which can be accessed by a general purpose orspecial purpose computer or other machine with a processor. Wheninformation is transferred or provided over a network or anothercommunications connection (either hardwired, wireless, or a combinationof hardwired or wireless) to a machine, the machine properly views theconnection as a machine-readable medium. Thus, any such connection isproperly termed a machine-readable medium. Combinations of the above arealso included within the scope of machine-readable media.Machine-executable instructions include, for example, instructions anddata which cause a general purpose computer, special purpose computer,or special purpose processing machines to perform a certain function orgroup of functions.

Although the figures may show a specific order of method steps, theorder of the steps may differ from what is depicted. Also two or moresteps may be performed concurrently or with partial concurrence. Suchvariation will depend on the software and hardware systems chosen and ondesigner choice. All such variations are within the scope of thedisclosure. Likewise, software implementations could be accomplishedwith standard programming techniques with rule based logic and otherlogic to accomplish the various connection steps, processing steps,comparison steps and decision steps. Other substitutions, modifications,changes and omissions may be made in the design, operatingconfiguration, and arrangement of the preferred and other exemplaryembodiments without departing from the spirit of the appended claims.

What is claimed is:
 1. A stimulation device for creating a pleasurablesensation in a user comprising: an expandable portion configured toassume a plurality of states of expansion between minimum expansion andmaximum expansion; a vibrating element extending away from an outersurface of the expandable portion; an electrode coupled to the outersurface of the expandable portion, the electrode configured to transmitelectrical current to a muscle in communication with the electrode; andwherein the expandable portion comprises a first portion and a secondportion, the electrode being supported by the first portion and notbeing directly coupled to the second portion, and wherein the first andsecond portion cooperate to cause the expandable portion to expand in acircumferentially non-uniform manner.
 2. The device of claim 1comprising processing electronics configured to cause an electricalsignal in the electrode and to control an aspect of vibration of thevibrating element.
 3. The device of claim 2, wherein the processingelectronics are configured to: determine a conductivity of anenvironment of the expandable portion; and control a contraction of themuscle in communication with the electrode in response to theconductivity of the environment of the expandable portion.
 4. The deviceof claim 2, wherein the processing electronics are configured to:determine whether the device is in an inserted position; and control acontraction of the muscle in communication with the electrode inresponse to a determination that the device is in the inserted position.5. The device of claim 2, wherein the processing electronics areconfigured to: determine that a pressure inside the expandable portionhas reached a predetermined value; and control a contraction of themuscle in communication with the electrode in response to adetermination that the pressure inside the expandable portion hasreached the predetermined value.
 6. The device of claim 1, wherein thevibrating element is configured to impart vibration to a first portionof the user's body.
 7. The device of claim 1 comprising a secondvibrating element configured to impart vibration to a second portion ofuser's body.
 8. The device of claim 1, wherein the expandable portion isconfigured to be inserted into a vagina.
 9. The device of claim 1comprising a pump in communication with the expandable portion andconfigured to cause expansion of the expandable portion.
 10. The deviceof claim 1, wherein the electrode is formed of an expandable material.11. The device of claim 10, wherein the expandable material is anelectrically conductive silicone rubber.
 12. The device of claim 1,wherein a radial thickness of the first portion is greater than a radialthickness of the second portion.
 13. The device of claim 1, wherein thesecond portion comprises at least one fold.
 14. A stimulation device forcreating a pleasurable sensation in a user comprising: a housing; ashaft having a proximal end and a distal end, the proximal end beinginterconnected to the housing; an operative portion located between theproximal end and the distal end and configured to be located within atleast one of a vagina, an anal canal, and a rectum when the device is inan inserted position; only one balloon circumferentially surrounding theoperative portion of the shaft; and a first electrode and a secondelectrode, the first and second electrodes coupled to an outer surfaceof the balloon and configured to cause a contraction of a muscle incommunication with the electrodes; wherein the balloon is configured toselectively inflate such that the first and second electrodes pressagainst at least one wall of the at least one of a vagina, an analcanal, and a rectum, wherein the balloon comprises a folded portionhaving at least one fold and configured to cause the balloon to inflatein a radially non-uniform manner, and wherein neither the firstelectrode nor the second electrode is directly coupled to the foldedportion.
 15. The device of claim 14, wherein the only one balloonsurrounds the entire portion of the shaft located within the at leastone of a vagina, an anal canal, and a rectum when the device is in aninserted position.
 16. The device of claim 14, wherein the housing iscoupled to the proximal end of the shaft so as to retain and fluidlyseal the balloon to the shaft.
 17. The device of claim 14, wherein thehousing covers a portion of the balloon.
 18. The device of claim 14,further comprising a pump located in the housing, in communication withthe balloon, and configured to cause inflation of the balloon.
 19. Thedevice of claim 14, wherein the entirety of the housing is not coveredby the balloon.
 20. A stimulation device for creating a pleasurablesensation in a user comprising: a shaft having a proximal end and adistal end, the proximal end being coupled to a handle; an operativeportion located between the proximal end and the distal end andconfigured to be located within a vagina when the device is in aninserted position; an expandable portion comprising an outer surface andconfigured to assume a plurality of states of expansion between minimumexpansion and maximum expansion, the expandable portioncircumferentially surrounding the operative portion of the shaft; afirst electrode and a second electrode, the first and second electrodesconfigured to cause a contraction of a muscle in communication with theelectrodes, the first electrode coupled to a first portion of the outersurface of the expandable portion, and the second electrode coupled to athird portion of the outer surface of the expandable portion, whereinthe expandable portion comprises a second portion having at least onefold, wherein neither the first electrode nor the second electrode isdirectly coupled to the second portion, and wherein the first, second,and third portions cooperate to cause the expandable portion to expandin a circumferentially non-uniform manner, and; a first vibratingelement extending away from the outer surface of the expandable portionand configured to impart vibration to a user's Gräfenberg Spot; a secondvibrating element configured to impart vibration to a first portion ofuser's body; a passageway for permitting a fluid from outside of thestimulation device to enter the expandable portion, the passagewayhaving at least one check valve along the passageway; a pump incommunication with the expandable portion and configured to move thefluid through the passageway to cause inflation of the expandableportion such that at least one of the first electrode, the secondelectrode, and the first vibrating element press against a vaginal wall;and processing electronics configured to cause an electrical signal inthe electrodes, to control an aspect of vibration of the first vibratingelement, and to control an aspect of vibration of the second vibratingelement.
 21. The device of claim 20, wherein the first portion of theuser's body is proximate the clitoris.